FDA Developing Accelerated Pathway For Devices for Unmet Needs, Hamburg Says

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By Bronwyn Mixter  

March 17 --Food and Drug Administration Commissioner Margaret A. Hamburg March 13 told a Senate committee that the agency is working to develop a new pathway to accelerate the review of devices for unmet medical needs.

The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing to examine the FDA's protection of public health through its oversight of medical products and food, as well as the agency's current priorities and initiatives.

Sen. Tammy Baldwin (D-Wis.) asked Hamburg about the new pathway and said the pathway “has the potential to improve treatment options.”

Hamburg said the FDA is “eager to work with industry” as the pathway moves forward.

“It's very important that we have the right incentives to get companies to develop products for essential medical needs,” Hamburg said.

Additionally, she said the Medical Device Innovation Consortium (MDIC), a public-private partnership, “has gotten off to a very good start.”

MDIC was created by Minnesota-based LifeScience Alley in 2012 . Its aim is to work in partnership with the FDA to improve the medical technology environment. Membership in the consortium is open to any organization involved in medical or medical device research, development, treatment or education.

Hamburg said the consortium focuses on how the underlying science can be advanced and specifically focuses on new clinical trial designs, patient-reported outcomes and computer simulation and models.

Drug Compounding

Hamburg also told the committee that the agency is working to develop current good manufacturing practice (cGMP) guidelines for outsourcing facilities that compound large volumes of drugs without individual prescriptions.

Hamburg said these cGMP guidelines for outsourcing facilities are a “high priority” for the agency and “we will get that out as quickly as we can.”

The Drug Quality and Security Act (DQSA), signed into law Nov. 27, 2013, distinguishes between compounders engaged in the traditional pharmacy practice of making customized drugs for specific patient needs from those making large volumes of compounded drugs without individual prescriptions. Compounders outside the scope of traditional pharmacy practice can register with the FDA as “outsourcing facilities” and become subject to federal oversight like traditional drug manufacturers.

Hamburg said 35 firms have already registered with the FDA as outsourcing facilities. However, she said she has some concerns that the registration is voluntary so some firms may choose not to register.

To highlight how the FDA and states are cooperating on the issue of compounding, Hamburg said the agency is holding a “50-state meeting” on this issue the week of March 17.

Concern Over Pain Drug

Sen. Tom Harkin (D-Iowa), chairman of the HELP Committee, also questioned Hamburg on why the agency approved the pain drug Zohydro ER when its own advisory panel voted against recommending approval of the drug.

In October 2013, the FDA approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for managing pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate. Zohydro ER is the first FDA-approved, single-entity (not combined with an analgesic such as acetaminophen) and extended-release hydrocodone product. The product is manufactured by Zogenix Inc., which is based in San Diego. The company has said it plans to launch the product in March.

In December 2012, an FDA advisory panel voted against recommending approval of Zohydro ER.

Harkin said Zohydro ER is 10 to 20 times more powerful than OxyContin, and the Zohydro ER capsule is easy to crush, which might lead to abuse of the drug.

Zohydro ER is “a very important treatment for legitimate pain,” Hamburg said.

Previously, hydrocodone was available only in a combination drug with acetaminophen, which has liver toxicity, Hamburg said. Zohydro “is unique as a single hydrocodone product without acetaminophen and liver risk.”

Hamburg also said Zohydro is a Schedule II controlled substance under the Controlled Substances Act, so there are additional restrictions for prescribing it. The drug also has a risk evaluation and mitigation strategy (REMS) that places further restrictions on its use and requires physician training.

“Appropriately used, it serves an important and unique niche,” Hamburg said. “We weigh carefully risks and benefits.”

Other senators and consumer groups have questioned the FDA's approval of Zohydro ER. Most recently, on March 10, Sen. Joe Manchin III (D-W.Va.) sent a letter to the Department of Health and Human Services, asking the agency to overturn the FDA's approval of the drug. Additionally, on Feb. 26, a coalition of more than 40 consumer organizations, health-care groups, addiction treatment providers and community-based drug and alcohol prevention programs sent a letter to the FDA asking it to revoke its approval of Zohydro ER.

Hamburg also told the committee that the FDA is working on encouraging the development of abuse-deterrent formulations of opioid pain drugs.


To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

Text of Hamburg's testimony before the Senate committee is at http://www.help.senate.gov/imo/media/doc/Hamburg4.pdf.